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Class 2 Device Recall Percuvance Percutaneous Surgical System |
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Date Initiated by Firm |
September 09, 2016 |
Date Posted |
October 07, 2016 |
Recall Status1 |
Terminated 3 on August 25, 2017 |
Recall Number |
Z-0059-2017 |
Recall Event ID |
75130 |
510(K)Number |
K143299
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Product Classification |
Laparoscope, general & plastic surgery - Product Code GCJ
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Product |
Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709
The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery. |
Code Information |
Lot Number 73M1500176 |
Recalling Firm/ Manufacturer |
Teleflex Medical 2917 Weck Dr Research Triangle Park NC 27709-0186
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For Additional Information Contact |
Melissa Lewis 610-378-0131
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Manufacturer Reason for Recall |
The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers.
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FDA Determined Cause 2 |
Process control |
Action |
The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" Letter dated 9/9/2016 to consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any products listed; to return product- complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com even if you do not have the affected product.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990. |
Quantity in Commerce |
160 ea. in total |
Distribution |
US Distribution to states of: AZ, CA, FL, NY, NC, and TX. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = GCJ and Original Applicant = Teleflex Medical, Inc.
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